Replies to post #4683 on GTC Biotherapeutics (fka GTCB)

[kris_kade]

Thanks for the clarification.

[kris_kade]

Dew,

Per information posted on the govt. clinical trial site,

http://www.clinicaltrials.gov/ct/show/NCT00506519;jsessionid=A2E3DEF0A70B56B59173DF6D7219AAC9?order=...

Further study details as provided by LEO Pharma:

Primary Outcome Measures:
Patients alive on day 28 having had an improvement in DIC score and having had no worsening on organ failure score.

Secondary Outcome Measures:
Mortality at 28 and 90 days. Change in organ failure score and DIC score. Pharmacokinetic (PK) parameters.


The Primary Outcome clearly says the Patients need to be alive on Day 28 while only improvement is needed in DIC score.

Is this not considered as Survival benefit (that needs to be met) ?

TIA

[shears]

Perhaps an n of 200 would be powered to show a statistically significant difference in survival benefit if RRR is over 35%? Leo could hit their secondary outcome measure if that is the case. Wasn't there a Meta-analysis that showed statistically significant survival benefit even with the heparin arms included?